Titolazioni dei preparati galenici oleosi a base di cannabis in Regione Liguria: progetto sperimentale dei laboratori di riferimento regionale

Analysis of cannabinoids concentration in cannabis oil galenic preparations in the Liguria Region: experimental project of the regional reference laboratories. Introduction: the medical use of cannabis is increasingly being applied in the treatment and support of several diseases and syndromes. In the Liguria Region, olive oil galenic preparations are mainly prepared by hospital pharmacies, according to common standard procedures. The preparations must be analyzed in order to establish the concentration of the two main active compounds (delta-9 tetrahydrocannabinol, THC and cannabidiol, CBD) thus allowing the correct setting of the therapeutic prescription. Liguria Region is at the forefront in the use of medical cannabis with a high number of patients treated (>1000). The aim of this work is to describe the organization of the titration activity centralized at the two regional reference laboratories (Central Laboratory of Analyses of Giannina Gaslini Institute, Genova and Toxicology Laboratory of Sarzana, La Spezia), coordinated by the inter-hospital department (DIAR) of the Laboratories Area. Methods: the phases of the analytical process (pre-analytical, analytical and post-analytical) have been identified and described. The analysis of the workflow has been carried out including the methods to prepare cannabis oil in the pharmacies, the intervals and production volumes, the medical-legal handling requirements and operational responsibilities. The definition of the pre-analytical phase foresees the methods of packaging, transport and recording of the samples and related responsibilities. Results: the analytical phase included the development and validation of the analytical method Ultra High Performance Liquid Chromatography coupled to tandem mass spectrometry, (UHPLC-MS/MS) in the two laboratories, with common procedures and the comparison of results conducted both on reference material and real samples of olive oil galenic preparations. The definition of the post-analytical phase included the reporting procedures. Discussion: the experimental phase has been concluded at the end of 2019 and the implementation phase of the project has started in march 2020.